SMC accepts Bijuve® (estradiol and progesterone) for estrogen deficiency symptoms in post-menopausal women for use by NHS Scotland

Embargoed. London, 13 September 2022: Theramex has announced that the Scottish Medicines Consortium (SMC) has accepted Bijuve® (1mg estradiol / 100mg progesterone) for use across NHS Scotland.

Bijuve® is the first, and only, body-identical hormone replacement therapy (HRT) indicated for estrogen deficiency symptoms in post-menopausal women (with intact uterus and at least 12 months since last menses), which combines estradiol and progesterone in a single daily oral capsule.1

The SMC is the body in Scotland that decides which medicines should be accepted for use by NHS Scotland. It considers clinical and health economic evidence, as well as evidence submitted by patient groups, to decide whether a medicine provides value for money.2

Acceptance by the SMC will ensure that women across Scotland will now be able to access this product. However, this is not the case in England where still only a handful of formularies have been updated to include this product. This is partly due to backlogs in formulary approvals caused by the COVID-19 pandemic3, as well as a lack of prioritisation of women’s health issues.

HRT is used to relieve symptoms of menopause, caused by hormone deficiency. The most common symptoms include hot flushes, night sweats, vaginal dryness and discomfort during sex, difficulty sleeping, low mood or anxiety, reduced sex drive (libido), problems with memory and concentration.4

There are different types of HRT, with treatments offering different combinations and dosages of hormones as well as different administration methods, including tablets, patches, gels and implants.5 Some HRT options contain body-identical hormones, it has been suggested that these hormones may be better tolerated and associated with fewer risks than synthetic hormones.6

National guidelines for the use of HRT recommend that an individualised approach should be adopted, allowing women to make informed choices, taking into consideration the types and forms of menopause treatments, as well as the benefits and risks.7,8

At Theramex we believe that all women requiring HRT should be offered a choice in their treatment so they can access the best treatment for them.

Dr Heather Currie, Gynaecologist and Associate Medical Director at Dumfries and Galloway Royal Infirmary, said, “This is really helpful for women in Scotland and will offer another option for women who choose to take HRT. There is not one type or regimen which suits all women and having more options takes us a step closer to ensuring women across all nations in the UK are able to find a preparation that suits them.”

Dr Paula Briggs, Consultant in Sexual and Reproductive Health and Chair of the British Menopause Society, said, “The availability of a body-identical progesterone is welcome news for the women of Scotland. I am pleased to see more options for the treatment of menopause becoming available. As clinicians, it is vital we empower our patients to make well informed choices on what is available and what works best for them.”

Tina Backhouse, UK General Manager, Theramex, said, “We are delighted that women in Scotland will now have access to a greater array of menopause treatments with the addition of Bijuve®. We do hope that timely adoption of Bijuve® onto local Scottish formularies is prioritised so women have access to more treatment choices. Theramex would welcome the introduction of a centralised national formulary in England, which would take us a step closer to equitable access for patients.”